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PubMed1989

Recombinant plasminogen activator inhibitor-1 reverses the bleeding tendency associated with the combined administration of tissue-type plasminogen activator and aspirin in rabbits.

The major side effect of thrombolytic therapy is bleeding; however, the pathogenesis of this potential complication is not well understood. Accordingly, we examined the effects of aspirin and recombinant human tissue-type plasminogen activator (rt-PA) on serial template bleeding times and on hemostasis parameters in rabbits. The administration of intravenous aspirin (15 mg/kg) produced a slight prolongation in bleeding times, from 2.1 +/- 0.5 to 2.6 +/- 0.5 min (mean +/- SD, n = 26, P less than 0.01), whereas rt-PA (1 mg/kg per h for 2 h) lengthened the bleeding time from 2.4 +/- 0.3 to 3.2 +/- 0.6 min (n = 5, P = NS). Combination of aspirin with 0.5 mg/kg per h of rt-PA for 2 h prolonged the bleeding time from 2.5 +/- 0.4 to 6.2 +/- 0.9 min (n = 10, P less than 0.01), with an associated fibrinogen decrease of approximately 15%. The combination of aspirin with 1 mg/kg per h of rt-PA for 2 h prolonged the bleeding time from 3.0 +/- 0.3 to 8.3 +/- 1.4 min (n = 8, P less than 0.01) and simultaneously induced a decrease of plasma fibrinogen by approximately 40%. Virtually all animals treated with rt-PA and aspirin manifested a bleeding tendency, as evidenced by spontaneous rebleeding at sites of previously performed template bleeding times or oozing at the femoral venous catheterization site. Intravenous bolus injection of 1 mg/kg of guanidine hydrochloride-reactivated recombinant human plasminogen activator inhibitor-1 (rPAI-1) at the end of the rt-PA infusion resulted in complete reversal, within 5 min, of the prolongation of the bleeding time, and in a disappearance of the bleeding tendency. Nonreactivated rPAI-1 and tranexamic acid were significantly less potent in reversing the bleeding time prolongation. These findings indicate that aspirin and rt-PA given separately do not markedly affect the template bleeding time, but in combination induce a marked prolongation associated with a significant bleeding tendency. This bleeding time prolongation can be rapidly normalized by the administration of reactivated rPAI-1.

Animals↗
PubMed2004

Evaluation of bleeding complications associated with glycoprotein IIb/IIIa inhibitors.

BACKGROUND: Platelet glycoprotein IIb/IIIa inhibitors are used with aspirin and heparin to decrease rates of death, myocardial infarction, and urgent revascularization in patients with acute coronary syndromes. OBJECTIVE: To determine whether bleeding event rates differed among 3 glycoprotein IIb/IIIa inhibitors prescribed in a high-risk, elderly veteran population and identify risk factors for bleeding. METHODS: A retrospective chart analysis of patients who received abciximab, eptifibatide, or tirofiban was conducted. chi(2) Analysis evaluated the incidence of bleeding complications, and stepwise regression analysis was utilized to identify bleeding risk factors. Parameters evaluated as possible risk factors for bleeding included age, renal function, weight, heparin and glycoprotein IIb/IIIa inhibitor dosing and infusion duration, concomitant antiplatelet and/or anticoagulant medications or disease states, and baseline hemoglobin, hematocrit, or platelet counts. RESULTS: Of 348 patients whose charts were reviewed, 79 patients were included. There were 37.9% who received abciximab (n = 30), 30.3% who received eptifibatide (n = 24), and 31.6% who received tirofiban (n = 25). Twenty-one bleeding events not related to coronary artery bypass grafting occurred: only 1 major bleed (tirofiban) and 20 minor bleeds. Bleeding rates were not significantly different between groups: abciximab 30% (n = 9), eptifibatide 21% (n = 5), and tirofiban 28% (n = 7). Significant risk factors for bleeding included patient weight, infusion duration, and baseline platelet count (p = 0.024). Patients who bled received significantly more transfusions of packed red blood cells and platelets than patients with no bleeding (p = 0.047). CONCLUSIONS: Although bleeding complications did not differ significantly between the 3 drugs, several risk factors for bleeding events were identified. A considerable rate of bleeding events occurred in this high-risk patient population.

Abciximab↗
PubMed2005

Mucosal polymerase chain reaction for diagnosing Helicobacter pylori infection in patients with bleeding peptic ulcers.

AIM: Helicobacter pylori (H pylori) has been linked to chronic gastritis, peptic ulcers, gastric cancer and MALT-lymphoma. Conventional invasive tests are less sensitive than non-invasive tests in diagnosing H pylori infection in patients with bleeding peptic ulcers. Polymerase chain reaction is a sensitive and accurate method for diagnosing H pylori infection. The aim of this study was to evaluate the diagnostic role of mucosal polymerase chain reaction for H pylori infection in patients with bleeding peptic ulcers. METHODS: In patients with bleeding, non-bleeding peptic ulcers and chronic gastritis, we checked rapid urease test, histology, bacterial culture and mucosal polymerase chain reaction for detecting H pylori infection. Positive H pylori infection was defined as positive culture or both a positive histology and a positive rapid urease test. For mucosal polymerase chain reaction of H pylori, we checked vacA (s1a, s1b, s1c, s2, m1, m1T, m2), iceA1, iceA2 and cag A. RESULTS: Between October 2000 and April 2002, 88 patients with bleeding peptic ulcers (males/females: 60/28, gastric ulcers/duodenal ulcers: 55/33), 81 patients with non-bleeding peptic ulcers (males/females: 54/27, gastric ulcers/duodenal ulcers: 45/36) and 37 patients with chronic gastritis (males/females: 24/13) were enrolled in this study. In patients with bleeding peptic ulcers, non-bleeding peptic ulcers and chronic gastritis, 45 patients (51%), 71 patients (88%) and 20 patients (54%) respectively were found to have positive H pylori infection (P<0.001). In patients with bleeding peptic ulcers, non-bleeding peptic ulcers and chronic gastritis, polymerase chain reaction for H pylori infection was positive in 54 patients (61%), 70 patients (86%) and 20 patients (54%) respectively (P<0.001). The sensitivity, positive predictive value and diagnostic accuracy of mucosal polymerase reaction for H pylori infection were significantly lower in patients with bleeding peptic ulcers (84%, 79% and 81%) than in patients with non-bleeding peptic ulcers (99%, 99% and 98%) (P<0.001, P<0.01 and P<0.001 respectively). The sensitivity, negative predictive value and diagnostic accuracy of mucosal polymerase reaction for H pylori were significantly lower in patients with bleeding peptic ulcers (84%, 83% and 81%) than in patients with chronic gastritis (100%, 100% and 100%) (P = 0.02, P = 0.02 and P = 0.001). CONCLUSION: Mucosal polymerase chain reaction for detecting H pylori infection is not reliable in patients with bleeding peptic ulcers.

Aged↗
PubMedDate not supplied

[Risk factors in the development of bleeding peptic ulcer].

INTRODUCTION: Gastric or duodenal peptic ulcer is the most common cause of bleeding from upper parts of the alimentary tract. Although there is a great number of these patients in the clinical practice, there are some contradictory characteristics in regard to the age of patient, localization of ulcer, the diameter of ulcer and Helicobacter pylori infection as possible risk factors in development of bleeding peptic ulcer. The aim of this work is evaluation of risk factors in our patients. MATERIAL AND METHODS: During this research we examened two groups of patients: a) first group consisted of patients with acute gastric or duodenal bleeding peptic ulcer, b) the second group consisted of patients without peptic ulcer bleeding. In both groups of patients we examined the most common risk factors for development of bleeding. This research took place in the Clinic for Surgery "Dr Dragisa Misović" in the period from January to December 1997. RESULTS: In both groups we had male predominance. Patients with bleeding peptic ulcers are statistically older when compared with the non-bleeding group (52.2 +/- 7.3:65.3 +/- 8.1). In both groups the anterior wall of the duodenum is the most common localization. In the group of bleeding ulcers we had high frequency of patients with localization of ulcers in the back wall of the duodenal bulb (20%). In this group of patients there was a high percentage of penetrating ulcers (62.5%) with active arterial bleeding (Forrest I a). Ulcers on the front wall of duodenal bulb and in small bend of stomach, as most common (over 50%), gave small peptic ulcers (under l cm) with capillary bleeding (oozing-Forrest I b) without haemodynamic complications. The presence of Helicobacter pylori infection is statistically significantly higher in the group of patients with bleeding peptic ulcers. DISCUSSION: The age of patients and localization of ulcer are very important and well known risk factors for development of bleeding peptic ulcer. However, in the last ten years Helicobacter pylori infection has become one of the most important risk factors. All Helicobacter pylori positive patients were treated with three component eradicational therapy for Helicobacter pylori. In this way we restricted the number of recurrent bleeding. CONCLUSION: In our opinion the age of patient, localization of ulcer, diameter and Helicobacter pylori infection are very important risk factors for development of bleeding peptic ulcer.

Adult↗
PubMed1991

Transcatheter control of intractible gastrointestinal bleeding.

A series of 23 patients with intractible gastrointestinal (GI) bleeding were managed by the transcatheter method. The series included 5 with hemobilia, 8 with upper GI (UGI) bleeding, 5 with lower GI (LGI) bleeding and 5 with variceal bleeding. The etiology of the hemobilia was surgery, or percutaneous transhepatic cholangiography and drainage (PTCD) complicated by various degrees of biliary tract infection. The causes of UGI bleeding included erosive gastritis, gastric and duodenal ulcers, and traumatic duodenal laceration. All 5 LGI bleedings were due to ischemic colitis and all 5 variceal bleedings were due to hyperdynamic portal hypertension from arterio-portal (A-P) shunting for hepatocellular carcinomas (HCC). Intra-arterial vasopressin infusion was performed on 17 (4, hemobilia; 8, UGI; and 5 LGI bleeding) of these 23 cases as initial management. The success rate for vasopressin in hemobilia, UGI and LGI bleeding was 75% (3/4), 38% (3/8), and 60% (3/5), respectively. The overall initial success rate of vasopressin was 52% (9/17). The relatively poor success rate of vasopressin infusion for UGI bleeding was due to ulcers and laceration. The incidence of rebleeding for vasopressin infusion was 22% (2/9) including one case each of UGI and LGI bleeding. Three patients (1 hemobilia and 2 UGI bleeding) among these 17 cases underwent transarterial embolization (TAE) after failure of intra-arterial vasopressin infusion. One of these 23 cases with hemobilia underwent TAE for initial transcatheter control of the GI bleeding. Five cases of active esophageal variceal bleeding, caused by A-P shunting in HCC, were all successfully controlled by TAE.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗
PubMed1991

Diagnostic emergency endoscopy in upper gastrointestinal bleeding--do we have any decision aids for patient selection?

The benefit of emergency endoscopy and therapeutic policies based on certain stigmata of bleeding has recently been demonstrated in patients with peptic ulcer hemorrhage. Applying a simple method of computer-aided diagnosis to a set of prospective data (n = 571) we investigated the question as to whether information on the history (28 variables) and clinical examination (8 variables) could be used to predict ulcer bleeding or certain stigmata of bleeding, with a view to deciding when to perform an emergency endoscopy in patients with upper gastrointestinal bleeding. The patients were assigned to either a high-risk group (probability greater than 0.50 for ulcer bleeding, arterial bleeding, etc.) or a low-risk group (p less than 0.50), and the prediction was compared with the actual findings at endoscopy. The results were disappointing, with an overall accuracy of 71% for the prediction of bleeding peptic ulcer and 71% for the prediction of a bleeding or non-bleeding visible vessel. Despite a relative risk of 2.8 for "bleeding ulcer" and 2.5 for "visible vessel" in the high-risk group, only 72% of all "bleeding ulcer" patients, and 69% of the "visible vessel" patients could be identified by the model. These results indicate that neither a bleeding ulcer nor stigmata of bleeding can be reliably predicted by the patient's history and clinical examination. Emergency endoscopy should therefore be performed in all patients with gastrointestinal bleeding.

Diagnosis, Computer-Assisted↗
PubMed1986

Endoscopic management of the bleeding ulcer. A survey.

The study was performed to evaluate the prognostic and therapeutic value of endoscopy in patients with bleeding ulcer. Before endoscopic control of ulcer bleeding was introduced 373 patients with bleeding ulcer and a median age of 67 years were studied retrospectively. Emergency surgery was required in 155 patients. The surgical mortality was 11% in 37 low risk patients, but 36% in 118 poor risk patients. There was a trend to improved outcome after introduction of diagnostic endoscopy but only in patients with hemorrhage managed conservatively. Surgical mortality remained unchanged. Ranked in order of prognostic importance, a complicating disorder, postoperative complications, overtransfusion, and absent past history of ulcer dyspepsia were identified as the most important determinants of fatal outcome. Age, onset of hemorrhage at home or in hospital, previous ulcer surgery, previous bleeds, ulcer site, and sex had comparatively less bearing on outcome. It was concluded that although surgery was efficient in preventing exsanguination, it was poorly tolerated in poor surgical risks who constituted 76% of the patients in need of emergency control of ulcer bleeding. The results indicate that the search for non-surgical methods is justified. In a pilot study, endoscopic electrocoagulation was applied to control ulcer bleeding in 60 patients. The experience from the study served as basis for a prospective study in an attempt to assess the prognostic and therapeutic potential of endoscopy in the management of bleeding ulcer and to define indications for emergency endoscopy. The histomorphologic effect of electrocoagulation employed to stop bleeding from acute gastric ulcers in rabbits suggested that intravascular occlusive fibrin thrombosis is the probable mechanism of hemostasis. In the prospective study, 539 consecutive patients admitted with hematemesis and melena underwent emergency endoscopy. Peptic ulcer, identified as the bleeding source in 51% of these patients, was the predominant lesion most liable to hemorrhage assessed as requiring emergency surgery. Black hematemesis with melena, occurring in 13% of the patients, was the best predictor of ulcer bleeding. Red hematemesis with melena (26%) was the most important predictor of major bleeding. Black hematemesis with melena was found to be as important as red hematemesis without melena (22%) in predicting major ulcer bleeding. In contrast, melena (18%) and, in particular, black hematemesis without melena (20%) were poor predictors of ulcer bleeding as well as of major bleeding.(ABSTRACT TRUNCATED AT 400 WORDS)

Electrocoagulation↗
PubMed1998

Bleeding symptoms and subsequent risk of gynecological and other cancers.

BACKGROUND: The purpose of our study was to find out whether bleeding symptoms are predictive factors of subsequent gynecological or urinary cancers among women screened negative. METHODS: The data stemmed from the Finnish Mass Screening Registry, and were linked to the National Cancer Registry: 37,596 screening negative women in the nationwide population-based mass screening program for cervical cancer were classified by their bleeding symptom (bloody discharge, coital bleeding, irregular bleeding, postmenopausal bleeding) at the time of screening (1985-1990) and followed up (1985-1994) in order to assess the subsequent risk of cancer. RESULTS: Bleeding symptoms with prevalence of 5.9% were more likely to be signs of preinvasive than invasive cervical cancer with the exception of coital bleeding, nevertheless relative risk of cervical cancer (SIR 1.1, 95% CI 0.8-1.4) was not significantly increased during the total follow-up of maximum 10 years. Women with any bleeding symptom had increased risk of cancer of the corpus uteri (SIR 2.1, 95% CI 1.6-2.6), postmenopausal bleeding was the strongest symptom (RR 3.6, 95% CI 2.0-6.0). None of the bleeding symptoms increased subsequent risk of ovarian, vaginal or vulvar carcinoma. The risk of kidney cancer was increased (SIR 1.7, 95% CI 1.0-2.6). CONCLUSIONS: The prevalence of bleeding symptoms was small and relative risks for cancers were low for them to be suitable as predictive factors of cancer neither in clinical practice nor for public health purposes, e.g. in developing selective screening based on this high risk group. Only 34 gynecological cancers during 220,000 person-years in women with bleeding symptoms were attributable to bleeding. Relative risks remained increased only for a short time after screening. Therefore, short term surveillance is important, but due to the fact that relative risks approached unity during the follow-up, reassurance of a woman that she is cancer-free should be emphasized more in the long term after the bleeding symptoms.

Adolescent↗
PubMed1988

The association between vaginal bleeding patterns and reasons for discontinuation of contraceptive use.

This paper describes the relationship between menstrual bleeding patterns recorded and reasons for discontinuing method use given by women using one of four types of hormonal contraception: combined oral pills, progestogen-only oral pills, a vaginal ring or depot-medroxyprogesterone acetate (DMPA). The women were recruited to five clinical trials, each of which lasted at least 48 weeks. The subject's reason for discontinuation was recorded if she stopped contraceptive use before the scheduled time. Overall, the reason expressed for discontinuing method use was a close reflection of the subject's experience. Among women using either type of oral contraceptive or a vaginal ring, subjects who discontinued for a non-menstrual reason or were lost to follow-up had bleeding patterns which did not differ markedly from those of women who continued method use. Only in the DMPA group was there any evidence that women who complained of non-menstrual side effects or were lost to follow-up might have ceased method use because they were unwilling or unable to tolerate their bleeding patterns. Subjects who discontinued because of amenorrhea had few bleeding/spotting days and at least one prolonged bleeding-free interval; women who complained of longer bleeding had long episodes and short intervals. Women who reported heavier bleeding had patterns which were similar to, but less extreme, than those of subjects who reported longer bleeding. The complaint of irregular bleeding, however, did not concur with the bleeding patterns recorded, regardless of contraceptive method. The predominant menstrual disturbance in this group of women was frequency of bleeding. They had no special difficulty in predicting either the time of onset or the length of their bleeding episodes. There were marked differences between individuals in terms of their acceptance of bleeding disturbances. Nevertheless, the results of this study confirm the importance of counselling. Women using DMPA tolerated far greater menstrual disruption than subjects using any other method. Subjects using an oral contraceptive were unlikely to have been warned of potential bleeding problems; when they encountered any, they tended to cease method use. In contrast, subjects using DMPA would have been advised to expect irregular patterns and possibly amenorrhea; prepared for such disturbances, their perseverance was remarkable.

Administration, Intravaginal↗
PubMed2002

Impact of calcium antagonists on bleeding time in patients with chronic renal failure.

Haemorrhagic diathesis develops in chronic renal failure, in which calcium antagonists are used widely as antihypertensive agents. Although calcium antagonists are reported to impair platelet function, it has not been examined whether calcium antagonists alter bleeding time. The present study was conducted to clarify whether calcium antagonists affect bleeding time in chronic renal failure. Patients with chronic renal failure without and with calcium antagonists were enrolled (n = 156), and bleeding time (Ivy's method) as well as blood parameters (BUN, creatinine, platelet counts, and haemoglobin) were compared in patients with normal and prolonged bleeding time. Among patients not taking calcium antagonists (n = 34), three cases manifested prolonged bleeding time, whereas abnormal bleeding time was observed in 31 patients out of 122. Positive correlations were observed between bleeding time and BUN in both calcium antagonist-untreated (r = 0.46) and -treated groups (r = 0.25). The odds ratio for prolongation of bleeding time in patients taking calcium antagonists was 3.52 (95% CI, 1.01-12.33). In 12 calcium antagonist-treated patients with prolonged bleeding time, the withdrawal of calcium antagonists markedly shortened bleeding time (from 11.3 +/- 0.8 to 5.4 +/- 0.8 min, P < 0.05, n = 12). In contrast, in the additional group (n = 9), the continued treatment with calcium antagonists had no effect on bleeding time (from 11.7 +/- 0.9 to 10.0 +/- 1.0 min). Despite the inhibitory effect of calcium antagonists on bleeding time, no clinically serious events associated with haemorrhagic diathesis developed. In conclusion, calcium antagonists prolong bleeding time in patients with chronic renal failure. The subclinical (laboratory) effect of calcium antagonists however is not necessarily associated with haemorrhagic events of clinical significance.

Aged↗
PubMed2005

Spontaneous bleeding associated with ginkgo biloba: a case report and systematic review of the literature: a case report and systematic review of the literature.

BACKGROUND: Ginkgo biloba (ginkgo) is a herbal remedy used by over 2% of the adult population in the United States. Several review articles have suggested that ginkgo may increase the risk of bleeding. OBJECTIVE: To report a case of bleeding associated with using ginkgo, to systematically review the literature for similar case reports, and to evaluate whether using ginkgo is causally related to bleeding. DATA SOURCES: We searched MEDLINE, EMBASE, IBIDS, and the Cochrane Collaboration Database from 1966 to October 2004 with no language restrictions. REVIEW METHODS: Published case reports of bleeding events in persons using ginkgo were selected. Two reviewers independently abstracted a standard set of information to assess whether ginkgo caused the bleeding event. RESULTS: Fifteen published case reports described a temporal association between using ginkgo and a bleeding event. Most cases involved serious medical conditions, including 8 episodes of intracranial bleeding. However, 13 of the case reports identified other risk factors for bleeding. Only 6 reports clearly described that ginkgo was stopped and that bleeding did not recur. Bleeding times, measured in 3 reports, were elevated when patients were taking ginkgo. CONCLUSION: A structured assessment of published case reports suggests a possible causal association between using ginkgo and bleeding events. Given the widespread use of this herb and the serious nature of the reported events, further studies are needed. Patients using ginkgo, particularly those with known bleeding risks, should be counseled about a possible increase in bleeding risk.

Aged↗
PubMed1990

Bleeding time in patients with hepatic cirrhosis.

OBJECTIVE: To determine the frequency of an abnormal bleeding time in patients with cirrhosis and to relate this to known factors that affect primary haemostasis and to the severity of liver disease. DESIGN: Prospective clinical and laboratory study in patients admitted for complications or investigations of liver disease. SETTING: Royal Free Hospital hepatobiliary and liver transplantation unit. SUBJECTS: 100 Consecutive inpatients aged 17-74 with various forms of cirrhosis, including alcoholic, biliary, autoimmune, viral, and cryptogenic. At least 10 days had elapsed since any episodes of bleeding, resolution of sepsis, or alcohol intake. No patient was taking any drug known to affect primary haemostasis. MAIN OUTCOME MEASURES: Bleeding time as measured with the Simplate double blade template device. A bleeding time longer than 10 minutes was considered abnormal. Other measures were platelet count, prothrombin time, partial thromboplastin time, packed cell volume, and blood urea, serum bilirubin, and serum albumin concentrations, all measured on each subject at the same time by standard laboratory methods. RESULTS: A weak but significant correlation existed between the bleeding time and the platelet count (rs = 0.483; p less than 0.001). There were significantly lower platelet counts, longer prothrombin times, and higher blood urea and serum bilirubin concentrations in the 42 patients with bleeding times of 10 minutes or more compared with the 58 patients with bleeding times less than 10 minutes. Multiple linear regression analysis showed that the bilirubin concentration as well as the platelet count was independently correlated with the bleeding time. The combination of a platelet count greater than 80 x 10(9)/l and a prothrombin time less than 17 seconds (usually taken as safe limits for performing routine liver biopsy) did not predict a normal bleeding time. Ten of 39 patients fulfilling these criteria had a prolonged bleeding time. CONCLUSIONS: Prolonged bleeding time is common in patients with cirrhosis, even in those with prothrombin times and platelet counts within "safe limits" for invasive procedures. The severity of liver disease as assessed by the bilirubin concentration plays an important part in determining the bleeding time in cirrhosis. The bleeding time should be measured when assessing patients for invasive procedures who have a raised bilirubin concentration or poor hepatic function, even if the platelet count and prothrombin time are considered adequate.

Adolescent↗
PubMed1988

Patients with prolonged bleeding time of undefined etiology, and their response to desmopressin.

Between 1981 and 1986, we evaluated 59 patients who presented with isolated prolongation of bleeding time with normal platelet counts, platelet aggregation and coagulation parameters (including von Willebrand's factor), and without evidence of liver or kidney disease, or exposure to anti-platelet agents. These patients, termed as vascular fragility syndrome (VFS), were analyzed to further characterize their bleeding patterns. The pattern of bleeding manifestations was similar to that of patients with platelet dysfunction, such as mucocutaneous bleeding or excessive post-operative bleeding. In 16 patients, desmopressin (1-desamino-8-d-arginine vasopressin, DDAVP) was infused to control active bleeding or as a part of pre-surgical evaluation. Bleeding time improved (pre-DDAVP bleeding time 15.3 +/- 3.4 min, mean +/- S.D.; post-DDAVP bleeding time 10.7 +/- 3.9 min; p less than 0.01) within 30 minutes following the DDAVP infusion with either satisfactory arrest of acute bleeding or good control of subsequent hemostasis with surgery. Side effects with DDAVP were transient and minor, i.e. facial flushing, or conjunctival erythema. These findings indicate that VFS with isolated prolongation of bleeding time is a frequently encountered bleeding disorder and that DDAVP is effective in achieving hemostasis for the management of acute bleeding and may be useful prior to surgical procedures.

Bleeding Time↗
PubMed1999

Bleeding during warfarin and aspirin therapy in patients with atrial fibrillation: the AFASAK 2 study. Atrial Fibrillation Aspirin and Anticoagulation.

BACKGROUND: Treatment with warfarin sodium is effective for stroke prevention in atrial fibrillation but many physicians hesitate to prescribe it to elderly patients presumably because of the associated risk for bleeding and the inconvenience of frequent blood tests for the patients. METHODS: In the Second Copenhagen Atrial Fibrillation, Aspirin, and Anticoagulation (AFASAK 2) Study, we studied the rate of bleeding events associated with the incidence of thromboembolic events in patients receiving warfarin sodium, 1.25 mg/d; warfarin sodium, 1.25 mg/d, plus aspirin, 300 mg/d; aspirin, 300 mg/d; or adjusted-dose warfarin therapy aiming at an international normalized ratio of the prothrombin time ratio (INR) of 2.0 to 3.0. The study was scheduled for 6 years from May 1, 1993, but owing to evidence of inefficiency of low-intensity therapy plus aspirin from another study it was prematurely terminated on October 2, 1996. Minor and major bleeding events were recorded prospectively. The rate of bleeding was calculated using the Kaplan-Meier method and risk factors were identified by the Cox proportional hazards model. RESULTS: Of 677 included patients, 130 (median age, 77 years; range, 67-89 years) experienced bleeding. One woman and 12 men experienced major bleeding. Four had intracranial bleeding: 2 cases were fatal and 2 were nonfatal. During treatment with mini-dose warfarin, warfarin plus aspirin, aspirin, and adjusted-dose warfarin, the annual rate of major bleeding was 0.8%, 0.3%, 1.4%, and 1.1%, respectively (P = .20). After 3 years of treatment the cumulative rate of any bleeding was 24.7%, 24.4%, 30.0%, and 41.1% (P = .003), respectively. Increasing INRvalue (P<.001) and prior myocardial infarction (P = .001) were independent risk factors for bleeding, whereas increasing age was not. CONCLUSIONS: Fixed mini-dose warfarin and aspirin alone or in combination were associated with both minor and major bleeding. The small number of major bleeding events in patients receiving adjusted-dose warfarin therapy as compared with those receiving less intensive antithrombotic treatments and the finding of no significant influence of age on the risk for bleeding indicate that even elderly patients with atrial fibrillation tolerate adjusted-dose warfarin therapy (INR, 2.0-3.0).

Adult↗
PubMed1999

Prediction of the risk of bleeding during anticoagulant treatment for venous thromboembolism.

OBJECTIVES: To construct and validate the bleeding risk prediction score, which is based on variables identified in the literature that can be easily obtained before the institution of anticoagulant therapy, in a large independent cohort of patients who were treated with anticoagulant therapy for established venous thromboembolism to allow for quantitative assessment of the risks and benefits of the therapy and to adapt the patient's management accordingly. METHODS: We constructed a bleeding risk prediction score, based on variables and their odds ratios identified in the literature, which can be easily obtained before the institution of anticoagulant therapy (score = [ 1.6 X age] + [1.3 x sex] + [2.2 X malignancy]). Subsequently, we evaluated the score in a test group of 241 patients treated with anticoagulant therapy for venous thromboembolism to determine the optimal cutoff points for the prediction of hemorrhagic complications, using receiver operating characteristic curve analysis. We then validated this score in an independent cohort of 780 patients. A score of 3 or more points, 1 to 3 points, or 0 points represented a high, intermediate, or low bleeding risk, respectively. RESULTS: The score in about one fifth of the patients in the test group was classified as predicting high risk for bleeding complications. The risk of all bleeding complications was 26% in this group and the risk of major bleeding complications was 14%. The area under the curve was 0.75 (95% confidence interval, 0.64-0.84) and 0.82 (95% confidence interval, 0.66-0.98) for all bleeding complications and major bleeding complications, respectively. When validated, there was a moderate loss of predictive power of the score, but the categorization of the patients by the score remained clinically useful; 20% of the patients were classified as high risk, and the bleeding rate was 17% for all bleeding complications and 7% for major bleeding complications compared with 4% and 1%, respectively, in those categorized as low risk. CONCLUSIONS: With the use of 3 easily obtainable, clinical variables in a prediction model, it is possible to identify a subgroup of patients at the start of anticoagulant therapy who have a high risk of developing hemorrhagic complications. Further studies should address whether additional measures to prevent bleeding decrease the bleeding incidence without compromising efficacy.

Anticoagulants↗
PubMed2004

How thick is too thick? When endometrial thickness should prompt biopsy in postmenopausal women without vaginal bleeding.

OBJECTIVE: Transvaginal sonography (TVS) is routinely performed as part of a pelvic sonogram in postmenopausal women, and images of the endometrium are frequently obtained. In women without vaginal bleeding, the threshold separating normal from abnormally thickened endometrium is not known. The aim of this study was to determine an endometrial thickness threshold that should prompt biopsy in a postmenopausal woman without vaginal bleeding. METHODS: This was a theoretical cohort of postmenopausal women aged 50 years and older who were not receiving hormone therapy. We determined the risk of cancer for a postmenopausal woman with vaginal bleeding when the endometrial thickness measures > 5 mm, and then determined the endometrial thickness in a woman without vaginal bleeding that would be associated with the same risk of cancer. We used published and unpublished data to determine the sensitivity and specificity of TVS, the incidence of endometrial cancer, the percentage of women symptomatic with vaginal bleeding, and the percentage of cancer that occurs in women without vaginal bleeding. Ranges for each estimate were included in a sensitivity analysis to determine the impact of each estimate on the overall results. RESULTS: In a postmenopausal woman with vaginal bleeding, the risk of cancer is approximately 7.3% if her endometrium is thick (> 5 mm) and < 0.07% if her endometrium is thin (< or = 5 mm). An 11-mm threshold yields a similar separation between those who are at high risk and those who are at low risk for endometrial cancer. In postmenopausal women without vaginal bleeding, the risk of cancer is approximately 6.7% if the endometrium is thick (> 11 mm) and 0.002% if the endometrium is thin (< or = 11 mm). The estimated risk of cancer was sensitive to the percentage of cancer cases that were estimated to occur in women without vaginal bleeding. For the base case we estimated that 15% of cancers occur in women without vaginal bleeding. When we changed the estimate to project that only 5% of cancers occur in women without vaginal bleeding, the projected risk of cancer with a thick measurement was only 2.2%, whereas when we estimated that 20% of endometrial cancers occur in women without bleeding, the projected risk of cancer with a thick measurement was 8.9%. As a woman's age increases, her risk of cancer increases at each endometrial thickness measurement. For example, using the 11 mm threshold, the risk of cancer associated with a thick endometrium increases from 4.1% at age 50 years to 9.3% at age 79 years. Varying the other estimates used in the decision analysis within plausible ranges had no substantial effect on the results. CONCLUSIONS: In a postmenopausal woman without vaginal bleeding, if the endometrium measures > 11 mm a biopsy should be considered as the risk of cancer is 6.7%, whereas if the endometrium measures < or = 11 mm a biopsy is not needed as the risk of cancer is extremely low.

Aged↗
PubMed1989

Major bleeding in outpatients treated with warfarin: incidence and prediction by factors known at the start of outpatient therapy.

PURPOSE: To determine the incidence of major bleeding in outpatients treated with warfarin and to identify predictive factors known at the start of therapy. PATIENTS AND METHODS: The records of 565 patients starting outpatient therapy with warfarin upon discharge from a university hospital were reviewed. Follow-up information was obtained for 562 patients (99.5%). Bleeding was classified as major or minor using explicit criteria. The cumulative incidence of bleeding was estimated by means of survival analysis. Independent risk factors for major bleeding were identified using Cox regression analysis in 375 randomly chosen patients; they were tested in the remaining 187 patients. RESULTS: Major bleeding occurred in 65 patients (12%) and was fatal in 10 patients (2%). The cumulative incidences of major bleeding at one, 12, and 48 months were 3%, 11%, and 22%, respectively. The monthly risk of major bleeding decreased over time, from 3% during the first month of outpatient therapy to 0.3% per month after the first year of therapy. Five independent risk factors for major bleeding--age 65 years or greater, history of stroke, history of gastrointestinal bleeding, a serious comorbid condition (recent myocardial infarction, renal insufficiency, or severe anemia), atrial fibrillation--predicted major bleeding in the testing group; the cumulative incidence of major bleeding at 48 months was 2% in 57 low-risk patients, 17% in 110 middle-risk patients, and 63% in 20 high-risk patients. CONCLUSION: These findings provide a quantitative basis for evaluating the risk of major bleeding in individual patients at the start of outpatient therapy with warfarin. Whether the risk of bleeding can be reduced in high-risk patients without reducing the benefit of therapy remains to be determined.

Adolescent↗
PubMed1999

Major bleeding after hospitalization for deep-venous thrombosis.

PURPOSE: Most studies of oral anticoagulant-related bleeding have analyzed the incidence of adverse outcomes among patients with a variety of different conditions and without any comparison with a control group. We determined the incidence, time course, and risk factors associated with major bleeding after hospital discharge among patients with deep-vein thrombosis, and estimated the excess risk of bleeding associated with oral anticoagulant therapy. METHODS: A total of 22,000 adults were hospitalized in California for 3 or more days with a diagnosis of deep-venous thrombosis between January 1, 1992, and September 30, 1994. We determined the risk factors associated with readmission for bleeding. We compared the incidence of readmission for bleeding with comparison cohorts of patients with pneumonia or cellulitis who were matched for age, gender, race, and length of hospital stay. RESULTS: Of 21,250 patients with deep-venous thrombosis who were discharged without bleeding, 1.4% were readmitted for bleeding within 91 days; the rate was 2.7 times greater in the first 30 days than in the next 61 days. Risk factors for bleeding included hospitalization with gastrointestinal bleeding during the previous 18 months (relative hazard [RH] = 2.6, 95% confidence interval [CI]: 1.6 to 4.1), hospitalization with an alcohol-related diagnosis during the previous 18 months (RH = 2.6, 95% CI: 1.4 to 4.8), chronic renal disease (RH = 2.4, 95% CI: 1.4 to 4.2), female gender (RH = 1.7, 95% CI: 1.3 to 2.2), presence of a malignancy (RH = 1.6, 95% CI: 1.2 to 2.2), nonwhite race (RH = 1.6, 95% CI: 1.2 to 2.1), and age over 65 years (RH = 1.3, 95% CI: 1.0 to 1.7). Significantly more women (n = 40) had intracranial bleeding than men (n = 18, P = 0.02). In the comparison cohorts, the incidence of readmission for bleeding within 3 months of discharge was 0.7%, and the relative risk (RR) of readmission was greater in those with deep-venous thrombosis than in those with cellulitis (RR = 2.0, 95% CI: 1.6 to 2.5) or pneumonia (RR = 2.0, 95% CI: 1.7 to 2.5). CONCLUSIONS: The incidence of rehospitalization for bleeding was greatest in the first 30 days after discharge, and was approximately twice that seen in patients hospitalized for cellulitis or pneumonia. Further studies are needed to determine why women and nonwhite patients are at increased risk for anticoagulant-related bleeding.

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